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1.1 Monotherapy

DUTASTERIDE (dutasteride) soft gelatin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

improve symptoms,

reduce the risk of acute urinary retention (AUR), and

reduce the risk of the need for BPH-related surgery.

1.2 Combination with Alpha-adrenergic Antagonist

DUTASTERIDE in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.